Saturday, January 12, 2008

Will Cipla Going to Test or Taste the Changing IP Landscape?

Indian generic major Cipla has made the first wave of ripples in the tranquil IP landscape by informally announcing to launch the generic version of revolutionary anti-cancer patented drug Tarceva in domestic market. According to news sources, Cipla is likely to launch the generic product by next week in India and Roche (an exclusive licensee in India) too is likely to recourse for necessary legal action under the Indian Patent Law. Although largely famous for bringing cheap alternative medicines, Cipla also have the tendency fighting against third party intellectual property rights for critical life-saving drugs and is convinced that Tarceva is not patentable in India. Also, there is a possibility that Cipla may move an application for post-grant opposition at the Delhi Patent Office under section 25 (2) of the Patents Act, 1970.

If launched, this not only going to be a testing time for Cipla but a tough task for the Indian judiciary and Indian Patent Office to decide and deliver a fair and meticulous judgement, what may further decide the course of changing IP landscape in India. Delhi Patent Office has lately granted Pfizer the Indian Patent No. 196774 for Erlotinib Hydrochloride, the active ingredient in Tarceva jointly developed with OSI Pharmaceuticals. In 2000, following merger with Warner-Lambert and in order to meet the US Federal Trade Commission requirements, Pfizer granted all developmental and marketing rights for Erlotinib to OSI for a royalty-free, cashless license. OSI later commenced clinical development and trials for Erlotinib in alliance with Genentech and Roche, and entered into an agreement for the global development and commercialization of Erlotinib. Under the terms of the agreement, Genentech and OSI shared costs and profit-making for commercializing the product in the US and Roche took the responsibility for obtaining regulatory approval and commercialization in territories outside the US and pay OSI royalties on net sales of the product.

“Erlotinib is a derivative of anti-cancer drug Gefitinib” stated Dr. Gopakumar G. Nair, a Mumbai-based patent consultant, further adding that Delhi Patent Office has already denied the patent for Gefitinib and patent granted for its derivative Erlotinib “will not be strong and can be revoked through a post-grant opposition.” Even earlier during pre-grant opposition period the mail-box Application No. 537/DEL/1996 for Erlotinib was opposed by Hyderabad-based Natco Pharma, but was rejected by the Delhi Patent Office. Now only the time will tell, what will be Cipla’s next move? But surely it is going to testing or tasting time!